Is NICE blinded by £ signs?

It has been a concerning few weeks in regards to NICE recommendations and the future of cancer treatment. With 331,000 people in the UK diagnosed with cancer in 2011, the guidance issued by NICE as to what drugs can and can’t be used on the NHS to treat the disease is important to many people.

The below is designed to explain the process and reasons behind the latest decisions.

Impact

The recent guidance issued by NICE regarding breast cancer and prostate cancer treatment has concerned industry, the public and politicians alike, who feel that these decisions may reflect the uneasy relationship between pharmaceutical companies and NICE; one based purely on cost.

The breast cancer drug in question is Kadcyla (also known as trastuzumab emtansine). Sir Andrew Dillon, NICE’s Chief Executive, announced that it would not be made available on the NHS saying: “Although Roche (the pharmaceutical company who manufacture the drug) proposed a discount to the full list price of Kadcyla, it made little difference to its value for money, leaving it well above the top of our specially extended range of cost-effectiveness for cancer drugs”. Roche’s general manager, Dr Jayson Dallas, issued a strong response saying the rejection “demonstrates quite simply that their current system is broken, not fit for purpose and in need of a complete overhaul when it comes to advanced cancer”. In contrast, Breakthrough Breast Cancer came out in defence of NICE, saying that they had gone ‘over and above their usual process’ in regards to trying to make Kadcyla available on the NHS.

This news was swiftly followed by that of Zytiga (also known as abiraterone), a drug used to treat prostate cancer, which NICE decided will not be available on the NHS until men have received a course of chemotherapy first. The reasoningfor this, again, relates to the cost of the drug. Sir Dillon, NICE chief executive, stated: “We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way. However, the manufacturer’s own economic model demonstrated that the drug does not offer enough benefit to justify its price.” A decision that Owen Sharp, Chief Executive of Prostate Cancer UK, described as a ‘kick-in the teeth’ for patients.

On hearing the decision, Dr Peter Barnes, the Medical Director at Janssen, the pharmaceutical company who manufacture the drug, said: “We are very disappointed with this decision which, if it stands, will leave thousands of men in England in the advanced stages of prostate cancer with no option but to accept chemotherapy – which they may not necessarily need or want yet – before being eligible to receive abiraterone routinely on the NHS”.

Who controls the purse strings?

There is, clearly, a limited amount of money available to spend on new drugs. Of the £14bn spent, £12bn is spent on ‘branded’ medicines ie. Nurofen and the rest of the money is spent on ‘unbranded’ medicines. The £12bn spent on ‘branded’ medicine is decided by the Pharmaceutical Price Regulation Scheme (PPRS), which is a non-contractual agreement between the Department of Health and the Association of the British Pharmaceutical Industry (ABPI) that caps the price of branded drugs. This agreement is currently in place for the next two years.

It then falls to NICE to decide which new drugs to commission. This is done by using something called a quality-adjusted life year calculation, commonly known as a QALY calculation. QALYs are designed to estimate the years of life remaining for a patient following a particular treatment or intervention. To put this simply, one QALY is equal to 1 year of life in perfect health. The QALY is intended to ensure that all new drugs and procedures are assessed in the same manner, whether it is a knee replacement or new drug to treat cancer. Once NICE has worked out the QALY for a treatment they can calculate the ‘cost-per-QALY’, in line with the manufacturer’s set price.

NICE will not normally suggest a drug for use on the NHS if it costs more than £30,000 per QALY. However, there were changes to this system in 2009, with NICE deciding to allow drugs that cost up to £50,000 per QALY to be considered if the drug would extend a person’s life by between 3-18 months, this is called the ‘end-of-life’ criteria. Then in 2010, the Government launched the Cancer Drugs Fund, which has a completely separate budget of £200m each year to enable patients to access drugs that are not routinely funded by the NHS. However, this fund is currently due to come to an end in 2016.

The industry and the NHS need effective and pro-innovative value assessment for new medicines. Partnership is clearly the way forward given the shared interest in managing the medicines bill in the UK and providing the highest quality of care for patients.

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